- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01491464
A Pivotal Study of rhBMP-2/ACS/INTER FIX™ Device for Posterior Lumbar Interbody Fusion in Patients With Degenerative Disc Disease
A Clinical Investigation of Recombinant Human Bone Morphogenetic Protein-2 and Absorbable Collagen Sponge With the INTER FIX™ Device for Posterior Lumbar Interbody Fusion in Patients With Degenerative Disc Disease
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Has degenerative disc disease as noted by back pain of discogenic origin, with or without leg pain, with degeneration of the disc confirmed by patient history (e.g., pain [leg, back, or symptoms in the sciatic nerve distribution], function deficit and/or neurological deficit) and radiographic studies (e.g., CT, MRI, X-Ray, etc.) to include one or more of the following:
- instability (defined as angular motion >=5° and/or translation >= 4mm, based on Flex/Ext radiographs);
- osteophyte formation;
- decreased disc height;
- thickening of ligamentous tissue;
- disc degeneration or herniation; and/or
- facet joint degeneration.
- Has preoperative Oswestry score >=35.
- Has no greater than Grade 1 spondylolisthesis utilizing Meyerding's Classification (Meyerding HW, 1932.).
- Has single-level symptomatic degenerative involvement from L2 to S1.
- Is at least 18 years of age, inclusive, at the time of surgery.
- Has not responded to non-operative treatment (e.g., bed rest, physical therapy, medications, spinal injections, manipulation, and/or TENS) for a period of at least 6 months.
- If female of child-bearing potential, who is not pregnant or nursing, and who agrees to use adequate contraception for 16 weeks following surgery.
- Is willing and able to comply with the study plan and sign the Patient Informed Consent Form.
Exclusion Criteria:
- Had previous spinal fusion surgical procedure at the involved level.
- Has spinal instrumentation (which will not be removed) stabilizing the involved level.
- Has a condition which requires postoperative medications that interfere with fusion, such as steroids.
- Has been previously diagnosed with osteopenia, osteoporosis, or osteomalacia to a degree that spinal instrumentation would be contraindicated.
- Has presence of active malignancy.
- Has overt or active bacterial infection, either local or systemic.
- Is grossly obese, i.e., weight> 40% over ideal for their age and height.
- Has fever (temperature> 101°F oral) at the time of surgery.
- Has a documented titanium alloy allergy or intolerance.
- Is mentally incompetent. If questionable, obtain psychiatric consult.
- Has a Waddell Signs of Inorganic Behavior score of 3 or greater.
- Is a prisoner.
- Is an alcohol and/or drug abuser as defined by currently undergoing treatment for alcohol and/or drug usage.
- Is a tobacco user at the time of surgery.
- Has received drugs which may interfere with bone metabolism within two weeks prior to the planned date of spinal fusion surgery (e.g., steroids or methotrexate).
- Has a history of autoimmune disease (Systemic Lupus Erythematosus or Dermatomyositis).
- Has a history of exposure to injectable collagen implants.
- Has a history of hypersensitivity to protein pharmaceuticals (monoclonal antibodies or gamma globulins) or collagen.
- Has received treatment with an investigational therapy within 28 days prior to implantation surgery or such treatment is planned during the 16 weeks following rhBMP-2/ACS implantation.
- Has received any previous exposure to any/all BMP of either human or animal extraction.
- Has a history of allergy to bovine products or a history of anaphylaxis.
- Has history of endocrine or metabolic disorder known to affect osteogenesis (e.g., Paget's disease, renal osteodystrophy, Ehlers-Danlos syndrome, or osteogenesis imperfecta).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: rhBMP-2/ACS
|
The INTER FIX™ device containing recombinant human Bone Morphogenetic Protein (rhBMP-2) soaked into an absorbable collagen sponge (ACS).
Other Names:
|
Active Comparator: Autogenous bone
|
The INTER FIX™ device containing autogenous bone taken from the patient's iliac crest.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neurological Status
Time Frame: 24 month
|
Neurological status will be assessed preoperatively and postoperatively using a comprehensive neurological status scale.
|
24 month
|
Fusion
Time Frame: 24 month
|
Fusion is defined as:
|
24 month
|
Pain/Disability Status
Time Frame: 24 month
|
The self-administered Oswestry Low Back Pain Disability Questionnaire will be used.
Success for each individual patient will be defined as pain/disability improvement postoperatively according to the following definition: Preoperative Score - Postoperative Score >= 15
|
24 month
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Disc Height Measurement
Time Frame: 24 month
|
24 month
|
General Health Status (SF-36)
Time Frame: 24 month
|
24 month
|
Patient Satisfaction
Time Frame: 24 month
|
24 month
|
Patient Global Perceived Effect
Time Frame: 24 month
|
24 month
|
Hip (Donor Site) Pain
Time Frame: 24 month
|
24 month
|
Pain Status (back pain, leg pain)
Time Frame: 24 month
|
24 month
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- C-9806
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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